Assessment of stability of CD34+ cell products enriched by immunoselection from peripheral blood mononuclear cells during refrigerated storage

Krasna, Metka; Maličev, Elvira; Rozman, J.-Z.; Vrtovec, Bojan

doi:10.1016/j.transci.2017.07.011

Cited by 2 publications

(2 citation statements)

References 31 publications

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“…Anti-CD34 Haematopoietic stem cells [14,17,18,23,24,33,34,37,39,43,45,47,48,[54][55][56] Anti-CD3 T cells [38,40,45,47,48,50,52] Anti-CD19 Anti-CD20…”

Section: Cell Line Referencesmentioning

confidence: 99%

“…Lee et al 54 in their study showed that thawed UCB samples were stable up to 6 h after thawing, regardless of whether samples were stored at room temperature or at 4 C. On the other hand, Huang and colleagues reported that CD34+ cell viability decreased significantly after only 20 min when thawed UCB samples were stored at RT. 55 Krasna et al 56 evaluated the stability of the HSC products after immunoselection and reported that CD34+ cells after selection were less stable than CD34+ cells in leukapheresis product during refrigerated storage up to 6 days. Since the results of the studies conducted so far have varied depending on the type of cellular therapy products and storage conditions, each laboratory should perform a sample stability study as part of the validation protocol.…”

Section: Stability Of the Cellular Therapy Product Samplesmentioning

confidence: 99%

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Role of flow cytometry in evaluation of the cellular therapy products used in haematopoietic stem cell transplantation

Rimac

Bojanić

2022

Int J Lab Hematology

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“…Anti-CD34 Haematopoietic stem cells [14,17,18,23,24,33,34,37,39,43,45,47,48,[54][55][56] Anti-CD3 T cells [38,40,45,47,48,50,52] Anti-CD19 Anti-CD20…”

Section: Cell Line Referencesmentioning

confidence: 99%

Section: Stability Of the Cellular Therapy Product Samplesmentioning

confidence: 99%

Role of flow cytometry in evaluation of the cellular therapy products used in haematopoietic stem cell transplantation

Rimac

Bojanić

2022

Int J Lab Hematology

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A CD34+ Cell Enrichment Protocol of Hematopoietic Stem Cells in a Well-Established Quality Management System

Kilic

Bay

Yildirim

et al. 2019

Cells Tissues Organs

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Allogeneic stem cell transplantation applications have improved tremendously over the past quarter of a century. The use of new immunosuppressive protocols and elimination of T cells by CD34+ cell enrichment or T cell depletion on apheresis products increases the chance of using partially matched or haploidentical grafts. This is without increasing the risk of graft-versus-host disease, which is observed as a major complication of hematopoietic stem cell transplantation. The aim of this protocol is to evaluate the results obtained from 6 different process cycles performed on 6 different days. We used the CliniMACS Plus system located in our Cell and Tissue Manufacturing Center Quality Control Unit which is already calibrated as a class D room and includes a class A microbiological safety cabinet inside. The average purity of the end products was 95.66%, excluding only one end product which was 70%; this was higher than the values in current studies in the field. Superior to the reported studies, the CD3 quantity in each end product was below the dedicated thresholds. BactecTM FX40 blood culture system test results were detected as negative for each end product. Endotoxin testing suggested the absence of endotoxin within the products. The consistent outcomes obtained from these 6 different process cycles confirmed that the CliniMACS® Plus process cycles performed in accordance with our well-defined quality management system procedure is sufficient for the routine application of high-quality and safe CD34+ enrichment processes within our clean room area.

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Assessment of stability of CD34+ cell products enriched by immunoselection from peripheral blood mononuclear cells during refrigerated storage

Cited by 2 publications

References 31 publications

Role of flow cytometry in evaluation of the cellular therapy products used in haematopoietic stem cell transplantation

Role of flow cytometry in evaluation of the cellular therapy products used in haematopoietic stem cell transplantation

A CD34+ Cell Enrichment Protocol of Hematopoietic Stem Cells in a Well-Established Quality Management System

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